Drugs Authority In Contact With Uzbek Regulator: Mansukh Mandaviya On Cough Syrup-Linked Deaths

After Uzbekistan linked the death of 18 children to an India-manufactured cough syrup, Union Health Minister Mansukh Madaviya informed that the product samples are being tested in a Chandigarh lab.

Union Health Minister Mansukh Madaviya

Source : PTI

New Delhi: Union Health Minister Mansukh Madaviya on Thursday said that India's Central Drugs Standard Control Organisation (CDSCO) is in touch with the national drug regulator of Uzbekistan regarding reports of contaminated cough syrup leading to deaths of children in the country.

"Regarding reports from Uzbekistan concerning contaminated cough syrup made by Indian company Marion Biotech, Noida, Uttar Pradesh, the @CDSCO_INDIA_INF  is in regular contact with the national drug regulator of Uzbekistan since 27th December," he tweeted.

He added, "Immediately on receipt of the information, a joint inspection of Marion Biotech’s Noida facility was carried out by UP Drug Control and the CDSCO team. Further action as appropriate would be initiated based on the inspection report."

Immediately on receipt of the information, a joint inspection of Marion Biotech’s Noida facility was carried out by UP Drug Control and the CDSCO team. Further action as appropriate would be initiated based on the inspection report. (2/3)

— Dr Mansukh Mandaviya (@mansukhmandviya) December 29, 2022

"The samples of the cough syrup have been taken from the manufacturing premises and sent to Regional Drugs Testing Laboratory, Chandigarh for testing," the Health Minister further informed.

The response comes after Pharmaceutical Firm Marion Biotech Pharma Company's legal head said that the manufacturing of its cough syrup has been halted after Uzbekistan linked the deaths of 18 children to the product.

"We regret deaths, government is conducting enquiry. We'll take action as per report. Samples were collected. Manufacturing of that product has been halted as of now and other processes are underway," Hasan Harris, Marion Biotech Pharma Company legal head, said, as per news agency ANI.

The Congress party also demanded the "strictest" action following the Uzbekistan government's claim.

Taking to Twitter, Congress General Secretary Jairam Ramesh said: "Made in India cough syrups seem to be deadly. First it was the deaths of 70 kids in Gambia & now it is that of 18 children in Uzbekistan. Modi Sarkar must stop boasting about India being a pharmacy to the world & take strictest action."

Made in India cough syrups seem to be deadly. First it was the deaths of 70 kids in Gambia & now it is that of 18 children in Uzbekistan. Modi Sarkar must stop boasting about India being a pharmacy to the world & take strictest action.

— Jairam Ramesh (@Jairam_Ramesh) December 29, 2022

The press statement from the Uzbekistan Health Ministry identified two factors behind the tragedy -- excess doses of the medicine in kids who don't require the drug and contamination of ethylene glycol -- one of the two toxic chemicals found in the Gambian case.

"To date, 18 out of 21 children with acute respiratory disease have died as a result of taking Doc-1 Max syrup manufactured by the Indian company Marion Biotech Pvt Ltd," the Uzbekistan Health Ministry mentioned in a statement, as quoted by news agency IANS.

"It was found that the deceased children, before admission to hospital treatment, took this drug at home for 2-7 days 3-4 times a day, 2.5-5 ml, which exceeds the standard dose of the drug for children," it added.

The Uzbek Ministry also stated, "All children were given the drug without a doctor's prescription. Since the main component of the drug is paracetamol, Doc-1 Max syrup was incorrectly used by parents as an anti-cold remedy on their own or the recommendation of pharmacy sellers. This was the reason for the deterioration of the condition of patients."

"Preliminary laboratory studies have shown that this series of Doc-1 Max syrup contains ethylene glycol. This substance is toxic, and about 1-2 ml/kg of a 95% concentrated solution can cause serious changes in the patient's health, such as vomiting, fainting, convulsions, cardiovascular problems and acute kidney failure," Uzbekistan authorities mentioned, as per IANS.

The World Health Organization in October flagged the presence of ethylene glycol and diethylene glycol as toxic contaminants in four cough syrup samples (made by Maiden Pharmaceuticals, Haryana) that are reportedly linked to the deaths of 70 children in The Gambia.

(With Agency Inputs)